A five-year follow-up of untreated patients with chronic lymphocytic leukaemia treated with ofatumumab and chlorambucil: final analysis of the Complement 1 phase 3 trial.
Aged
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Chlorambucil
/ administration & dosage
Disease-Free Survival
Female
Follow-Up Studies
Humans
Leukemia, Lymphocytic, Chronic, B-Cell
/ drug therapy
Male
Middle Aged
Survival Rate
Complement 1
anti-CD20 monoclonal antibodies
chlorambucil
chronic lymphocytic leukaemia
ofatumumab
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
21
01
2020
accepted:
09
03
2020
pubmed:
3
4
2020
medline:
10
3
2021
entrez:
3
4
2020
Statut:
ppublish
Résumé
The Complement 1 trial investigated the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia (CLL). On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free survival, respectively. A high rate (61%) of treatment with next-line therapies in both the treatment arms may dilute any potential OS difference and confound the interpretation of the OS results. Addition of ofatumumab to chlorambucil demonstrated clinical benefit and tolerability as a frontline treatment option in patients unfit for fludarabine-containing therapy, with no new safety concerns.
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Chlorambucil
18D0SL7309
ofatumumab
M95KG522R0
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
736-740Subventions
Organisme : Novartis Pharma AG
Informations de copyright
© 2020 British Society for Haematology and John Wiley & Sons Ltd.
Références
Parikh SA. Chronic lymphocytic leukemia treatment algorithm 2018. Blood Cancer J. 2018;8:93.
Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M et al First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood. 2009;114:3382-91.
Burger JA, Barr PM, Robak T, Owen C, Ghia P, Tedeschi A et al Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study. Leukemia. 2020;34:787-98.
Kater AP, Seymour JF, Hillmen P, Eichhorst B, Langerak AW, Owen C et al Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: post-treatment follow-up of the MURANO phase III study. J Clin Oncol. 2019;37:269-77.
Evers M, Jak M, Leusen JHW. The latest developments with anti-CD20 monoclonal antibodies in chronic lymphocytic leukemia. Expert Opin Biol Ther. 2018;18:973-82.
Foa R, Del Giudice I, Cuneo A, Del Poeta G, Ciolli S, Di Raimondo F et al Chlorambucil plus rituximab with or without maintenance rituximab as first-line treatment for elderly chronic lymphocytic leukemia patients. Am J Hematol. 2014;89:480-6.
Goede V, Fischer K, Bosch F, Follows G, Frederiksen H, Cuneo A et al Updated survival analysis from the CLL11 study: obinutuzumab versus rituximab in chemoimmunotherapy-treated patients with chronic lymphocytic. Leukemia. 2015;126:1733.
Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM et al Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370:1101-10.
Hillmen P, Gribben JG, Follows GA, Milligan D, Sayala HA, Moreton P et al Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: final analysis of an open-label phase II study. J Clin Oncol. 2014;32:1236-41.
Laurenti L, Vannata B, Innocenti I, Autore F, Santini F, Piccirillo N et al Chlorambucil plus rituximab as front-line therapy in elderly/unfit patients affected by B-cell chronic lymphocytic leukemia: results of a single-centre experience. Mediterr J Hematol Infect Dis. 2013;5:e2013031.
Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S et al Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015;385:1873-83.
Michallet AS, Aktan M, Hiddemann W, Ilhan O, Johansson P, Laribi K et al Rituximab plus bendamustine or chlorambucil for chronic lymphocytic leukemia: primary analysis of the randomized, open-label MABLE study. Haematologica. 2018;103:698-706.
Dlugosz-Danecka M, Jurczak W, Latka-Cabala E, Morawska M, Gawronski K, Wisniewska A et al Efficacy and safety of the obinutuzumab-chlorambucil combination in the frontline treatment of elderly CLL patients with comorbidities - Polish Adult Leukemia Group (PALG) real-life analysis. Pol Arch Intern Med. 2018;128:421-6.